510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,618

176,415 records, page 502 of 3529

510(k) clearances, page 502 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K182569	Spectralis HRA+OCT and variants with High Magnification Module	Heidelberg Engineering GmbH	OBO	Class II	2018-10-18
K182348	14Hk701g-W	LG Electronics.Inc	MQB	Class II	2018-10-18
K182239	OLYMPIC Posterior Spinal Fixation System	Astura Medical	NKB	Class II	2018-10-18
K181945	QuickScreen Pro Multi Drug Screening Test, Model 9395Z	Phamatech Inc.	DKZ	Class II	2018-10-18
K181942	Quantum Ventilation Module	Spectrum Medical Inc	DTX	Class II	2018-10-18
K181941	Swift System	Emblation Limited	NEY	Class II	2018-10-18
K181803	Medax Biopsy Systems III	Medax S.r.l. Unipersonale	KNW	Class II	2018-10-18
K181718	BD FlowSmart Set/MiniMed Pro-Set	Becton Dickinson & Co	FPA	Class II	2018-10-18
K181618	Reprocessed Torqr Diagnostic EP Catheter	Innovative Health, LLC.	NLH	Class II	2018-10-18
K181373	Extended Lipid Panel Assay	Laboratory Corporation of America Holdings	CHH	Class I	2018-10-18
K180708	Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit	Xeridiem Medical Devices, A Spectrum Plastics Group Company	PIF	Class II	2018-10-18
K180474	TNI softFlow 50	Tni Medical AG	BTT	Class II	2018-10-18
K182669	Youlaser CO2	Quanta System Inc.	GEX	Class II	2018-10-17
K182551	Wireless Digital Flat Panel Detector	Iray Technology Taicang, Ltd.	MQB	Class II	2018-10-17
K182550	Wireless Digital Flat Panel Detector	Iray Technology Taicang, Ltd.	MQB	Class II	2018-10-17
K182546	Alphenix, INFX-8000H/B, V8.0	Canon Medical Systems Corporation	OWB	Class II	2018-10-17
K182240	PASS LP Spinal System	Medicrea International	NKB	Class II	2018-10-17
K182034	Arterys MICA	Arterys Inc.	LLZ	Class II	2018-10-17
K181728	Muscle Trainer	Shenzhen Kentro Medical Electronics Co., Ltd	NGX	Class II	2018-10-17
K181026	OsteoBridge™ IDSF System	Merete GmbH	HSB	Class II	2018-10-17
K180941	Ortho System	3Shape A/S	PNN	Class II	2018-10-17
K180345	Uroject12 Syringe Lever	Urogen Pharma Ltd.	QBL	Class II	2018-10-17
K180240	Full Automatic(NIBP) Blood Pressure Monitor	Health & Life Corporation	DXN	Class II	2018-10-17
K172709	ELAN 4 Electro Motor System Tools	Aesculap Inc	HBE	Class II	2018-10-17
K182614	Rct700	Ray Co., Ltd.	OAS	Class II	2018-10-16
K182261	NvisionVLE Imaging System, NvisionVLE Optical Probe	Ninepoint Medical, Inc.	NQQ	Class II	2018-10-16
K182154	Depuy Synthes Femoral Neck System	Synthes (USA) Products LLC	KTT	Class II	2018-10-16
K181937	Pump In Style Advanced, Advanced Personal Double Breastpump	Medela AG	HGX	Class II	2018-10-16
K180971	QUANTA Flash Calprotectin and Fecal Extraction Device	Inova Diagnostics, Inc.	NXO	Class II	2018-10-16
K180568	KidCap	Eastern Cranial Affiliates	MVA	Class II	2018-10-16
K182233	FlowTriever Retrieval/Aspiration System	Inari Medical, Inc.	QEW	Class II	2018-10-15
K182036	NeuroBlate System	Monteris Medical Corp	GEX	Class II	2018-10-15
K181910	BracePaste MTP Light Cure Primer	American Orthodontics	KLE	Class II	2018-10-15
K181815	DynaBridge	Fusion Orthopedics, LLC	JDR	Class II	2018-10-15
K180418	Reliant(TM) Multistage Dilatation Balloon Catheter	Micro-Tech (Nanjing) Co., Ltd.	FGE	Class II	2018-10-15
K182536	Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap	Exactech, Inc.	PHX	Class II	2018-10-12
K182522	Penumbra System (Modified 110 Aspiration Tubing)	Penumbra Inc.	NRY	Class II	2018-10-12
K182504	3.0T Air MP M, 3.0T Air MP L	GE Healthcare Coils (USA Instruments, Inc.)	MOS	Class II	2018-10-12
K182247	ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)	Vizionfocus Inc.	LPL	Class II	2018-10-12
K182237	uMI 550 PET/CT System	Shanghai United Imaging Healthcare Co., Ltd.	KPS	Class II	2018-10-12
K182129	MAGNETOM Sola	Siemens Medical Solutions USA, Inc.	LNH	Class II	2018-10-12
K181999	Integra TITAN Reverse Shoulder System	Integra LifeSciences Corporation	PHX	Class II	2018-10-12
K181852	Percuvance Percutaneous Surgical System	Teleflexmedical, Inc.	GEI	Class II	2018-10-12
K181848	ADAPT for Gamma3, Gamma3	Stryker Corp.	OLO	Class II	2018-10-12
K181717	Life Spine Laminoplasty System	Life Spine	NQW	Class II	2018-10-12
K181651	Radial Medical Compression System	Radial Medical, Inc.	JOW	Class II	2018-10-12
K181644	EIT Cellular Titanium® Lumbar Cage LLIF	Eit Emerging Implant Technologies GmbH	MAX	Class II	2018-10-12
K181640	X-BOLT Hip Fracture Fixation System	X-Bolt Orthopaedics	HSB	Class II	2018-10-12
K181607	Thorecon Rigid Fixation System	A & E Medical Corporation	JDQ	Class II	2018-10-12
K181569	BKS Revision Sleeves System	Ortho Development Corp.	JWH	Class II	2018-10-12